FDA Advisory Committee Wants Stronger Warning for Serevent

The FDA’s Pediatric Advisory Committee recommended that the agency strengthen the boxed warning for GlaxoSmithKline’s (GSK) asthma treatment Serevent to reflect the risks of the product in children.

The agency convened the advisory committee meeting Nov. 28 to discuss the safety of the drug after serious pediatric adverse events, including patient deaths, were reported for Serevent (salmeterol xinafoate) between March 2006 and April 2007.

Andrew Mosholder, a medical officer with the FDA’s Division of Drug Risk Evaluation, told the committee that agency drug safety staff became concerned with the use of the product in children when a review of adverse event data revealed five patient deaths in children younger than 16.

Although there was not a formal vote on the matter, committee Chairwoman Marsha Rappley, acting dean of the College of Human Medicine at Michigan State University, said the committee wanted the existing boxed warning in Serevent physician labeling to identify the risks of the drug in children.

GSK added the boxed warning for asthma-related deaths two years ago, although at the time the firm disagreed with the FDA’s assessment that the product increased the risk of severe asthma episodes.

The committee requested the FDA move to a more prominent position a statement in the labeling recommending the drug only be used as a second-line treatment. A statement regarding the drug’s risk in black patients also was requested.

In addition, the committee wanted labeling to include information that characterized the risk of the product relative to other risks, such as driving a vehicle or playing sports, so doctors could consider the information when prescribing the medicine.

GSK said there is no new safety information that changes the risk-benefit evaluation of Serevent or warrants another review at this time.